Zenara Pharma Achieves Landmark U.S. FDA Approval for First Generic Sertraline Hydrochloride Capsules

Zenara Pharma Achieves Major Milestone with FDA Approval

Zenara Pharma Private Limited, a respected entity under Biophore, has officially received the green light from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA). This landmark approval pertains to Sertraline Hydrochloride Capsules, available in doses of 150 mg and 200 mg, marking the first FDA-approved generic version of the referenced product marketed by Almatica Pharma, LLC.

Zenara's newly approved capsules have been granted a Competitive Generic Therapy (CGT) designation by the FDA. This pathway secures Zenara 180 days of marketing exclusivity that started with the product's launch. This extraordinary achievement emphasizes Zenara's commitment to enhancing patient access to essential medications while demonstrating its robust research and development capabilities.

Sertraline Hydrochloride Capsules belong to the class of selective serotonin reuptake inhibitors (SSRIs) and are indicated for treating Major Depressive Disorder (MDD) in adults and Obsessive-Compulsive Disorder (OCD) in both adults and pediatric patients aged six years and older. Dr. Srinivas Arutla, CEO of Zenara Pharma, expressed his pride in this achievement, stating: "Receiving the first generic approval for Sertraline Hydrochloride Capsules highlights Zenara's strong R&D capabilities and operational excellence. We remain committed to our mission of delivering to patients early access to high-quality, affordable pharmaceuticals."

In terms of market potential, IQVIA™ data shows that U.S. sales for the reference product reached approximately $35.5 million in the twelve months ending June 2025. This figure illustrates the significant opportunity Zenara Pharma has within the pharmaceutical landscape.

Zenara Pharma, a subsidiary of Biophore, is a vertically integrated pharmaceutical company dedicated to providing high-quality pharmaceuticals that are both safe and effective for patients. The company continues to emphasize research and development as a core aspect of its operational foundation, specifically focusing on areas such as Neurology, Orphan Drugs, Complex Products, Women's Health, Cardiology, Imaging, and Contrast Agents.

By receiving FDA approval for the first generic of Sertraline Hydrochloride Capsules, Zenara is not only poised to contribute positively to the pharmaceutical marketplace but is also setting a precedent for other companies in the industry aiming for similar achievements. As Zenara continues to grow and evolve, it remains committed to providing affordable and effective treatment options for patients worldwide.

For more updates on Zenara and its products, check out their website or connect with them on LinkedIn.

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